Active, not recruitingNo phase
Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication
Key facts
- Who runs it
- Endologix
- Where
- Atlanta, Camden, Columbia, Huntsville, Indianapolis, New York, Portland, and Washington D.C., United StatesSee the 8 sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 13 people enrolled
- Started
- 29 Jun 2020
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Treatments tested
- Chimney Endovascular Aortic Sealing (ChEVAS) System
- Record updated
- 21 April 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Adults at least 18-years old
- Subject provided informed consent
- Subject agrees to all follow-up visits
- Abdominal aortic aneurysm (AAA) with maximum sac diameter ≥5.0 cm, or ≥ 4.5 cm which has increased by ≥ 0.5cm within the last 6-months, or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4cm will be included
- Absence of significant cranial angulation of the visceral vessels that would preclude vessel cannulation and stenting
Who cannot take part
- Participating in another clinical drug and/or device study, which could confound the results of this study (patient must have completed the primary endpoint of any previous study at least 30-days prior to enrollment in this study)
- Prior stent in any target visceral vessel, the aorta or iliac artery that may interfere with delivery system introduction or stent placement
- Psychiatric or other condition that may interfere with the study
- Known allergy or contraindication to any device material, contrast, or anticoagulants
- Connective tissue diseases (e.g., Marfan Syndrome)
- Serum creatinine level >1.8mg/dL
- Requirement of home oxygen
- CVA or MI within three months of enrollment/treatment
- Unsuitable vascular anatomy that may interfere with device introduction or deployment
- Pregnant, planning to become pregnant within 60 months, or breast feeding
Where in United States
- Emory UniversityAtlanta, United StatesNo longer taking part
- Cooper University HospitalCamden, United StatesNo longer taking part
- University of MissouriColumbia, United StatesNo longer taking part
- Valley Vascular ConsultantsHuntsville, United StatesNo longer taking part
- St. Vincent Medical GroupIndianapolis, United StatesNo longer taking part
- Icahn School of Medicine at Mount SinaiNew York, United StatesNo longer taking part
- Providence PortlandPortland, United StatesNo longer taking part
- Medstar Health Research InstituteWashington D.C., United StatesNo longer taking part
About the trial
What the trial wants to find out
Prospective, multi-center, non-randomized study with consecutive, eligible subject enrollment at each site, for the evaluation of the ChEVAS System for Endovascular Repair of Complex Abdominal Aortic Aneurysms.
The group in the trial
- ChEVAS SystemTreatment being tested
The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.
Treatment: Chimney Endovascular Aortic Sealing (ChEVAS) System
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective, Multicenter, Non-randomized Study With Consecutive, Eligible Subject Enrollment at Each Site, for the Evaluation of the ChEVAS System for Endovascular Repair of Paravisceral, Juxtarenal, and Pararenal Abdominal Aortic Aneurysms.
- Record updated
- 21 April 2026